Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT01529294
Status:
COMPLETED
Last Update Posted:
2013-03-14
First Post:
2011-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C081732', 'term': 'iloperidone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-13', 'studyFirstSubmitDate': '2011-09-23', 'studyFirstSubmitQcDate': '2012-02-06', 'lastUpdatePostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure: Area Under Curve (AUClast, AUCinf) and maximum concentration (Cmax)', 'timeFrame': 'predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose', 'description': 'Pharmacokinetics of iloperidone in subjects with mild or moderate hepatic impairment, compared to healthy volunteers.'}, {'measure': 'Maximum plasma concentration following drug administration (Cmax) of iloperidone', 'timeFrame': 'pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose, and from pre-dose to 48 hours post-dose', 'description': 'Blood and urine samples will be collected and plasma and urine concentration will be measured.'}, {'measure': 'Protein binding of iloperidone', 'timeFrame': 'pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose, and from pre-dose to 48 hours post-dose', 'description': 'Blood samples will be collected and protein binding will be measured .'}, {'measure': 'Area under the plasma concentration-time Curve from time zero to infinity (AUCinf) of iloperidone', 'timeFrame': 'pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose, and from pre-dose to 48 hours post-dose', 'description': 'Blood and urine samples will be collected and plasma and urine concentration will be measured.'}], 'secondaryOutcomes': [{'measure': 'Area Under the plasma Curve (AUC) of iloperidone metabolite P88', 'timeFrame': 'pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose and from pre-dose to 48 hours post-dose', 'description': 'Blood and urine samples will be collected and plasma and urine concentrations of metabolite 88 will be measured'}, {'measure': 'Area under the plasma concentration-time Curve from time zero to infinity (AUCinf) of iloperidone metabolite P88 records, listed by subject. Summary statistics provided by impairment group and visit/time.', 'timeFrame': 'pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose and from pre-dose to 48 hours post-dose', 'description': 'Blood and urine samples will be collected and plasma and urine concentrations of metabolite 88 will be measured'}, {'measure': 'Maximum plasma concentration following drug administration (Cmax) of iloperidone metabolites P88', 'timeFrame': 'pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose and from pre-dose to 48 hours post-dose', 'description': 'Blood and urine samples will be collected and plasma and urine concentrations of metabolite 88 will be measured'}, {'measure': 'Protein binding of iloperidone metabolites P88 (CLr)', 'timeFrame': 'pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose and from pre-dose to 48 hours post-dose', 'description': 'Blood samples will be collected and protein binding of metabolite 88 will be measured'}, {'measure': 'Area Under the plasma Curve (AUC) of iloperidone metabolite P95', 'timeFrame': 'pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose and from pre-dose to 48 hours post-dose', 'description': 'Blood and urine samples will be collected and plasma and urine concentrations of metabolite 95 will be measured'}, {'measure': 'Area under the plasma concentration-time Curve from time zero to infinity (AUCinf) of iloperidone metabolite P95', 'timeFrame': 'pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose and from pre-dose to 48 hours post-dose', 'description': 'Blood and urine samples will be collected and plasma and urine concentrations of metabolite 95 will be measured'}, {'measure': 'Maximum plasma concentration following drug administration (Cmax) of iloperidone metabolites P95', 'timeFrame': 'pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose and from pre-dose to 48 hours post-dose', 'description': 'Blood and urine samples will be collected and plasma and urine concentrations of metabolite 95 will be measured'}, {'measure': 'Protein binding of iloperidone metabolites P95', 'timeFrame': 'pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post-dose and from pre-dose to 48 hours post-dose', 'description': 'Blood samples will be collected and protein binding of metabolite 95 will be measured'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'Day 6', 'description': 'Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on Electrocardiograms (ECGs)'}]}, 'conditionsModule': {'keywords': ['Hepatic impairment', 'Iloperidone', 'ILO522D', 'Pharmacokinetics'], 'conditions': ['Hepatic Impairment']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the pharmacokinetic profile and the tolerability of iloperidone in subjects with mild or moderate hepatic impairment comparatively to healthy matched subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria (all subjects):\n* Caucasian subjects\n* Inclusion criteria (hepatic impaired subjects):\n* subjects with physical signs consistent with a clinical diagnosis of stable liver disease, which has been confirmed by imaging techniques, ultrasound, Magnetic Resonance Imaging or Computed Tomogram within 3 months of screening, and a creatinine clearance \\> 50 mL/min (based on Cockroft and Gault formula).\n* Inclusion criteria (healthy volunteers):\n* good general health\n* matched by age, gender, smoking status, Body Mass Index, and CYP2D6 phenotype to hepatic impaired subjects.\n\nExclusion Criteria:\n\n* Exclusion criteria (all subjects):\n* Subjects who report smoking a pipe, cigars or more than 20 cigarettes per day .\n* History of drug abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening\n* History of first-dose response/syncope to alpha1-blocking agents\n* Exclusion criteria (Hepatic impaired subjects):\n* Patients with symptoms or 6 months past history of encephalopathy.\n* Patients with clinical evidence of moderate-severe ascites.\n* Patients having a previous surgical porto-systemic shunt.\n* Exclusion criteria (Healthy volunteers):\n* History of alcohol abuse prior to dosing, or evidence of such abuse during screening.\n* Pulse Rate \\> 200 msec\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01529294', 'briefTitle': 'Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Open-label, Single-dose, Parallel-group Study to Compare the PKs of Iloperidone in Subjects With Mild or Moderate Hepatic Impairment With That in Matched Healthy Control Subjects', 'orgStudyIdInfo': {'id': 'CILO522D2401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iloperidone', 'description': 'Eligible subjects receive a single oral dose of 2 mg iloperidone as a tablet', 'interventionNames': ['Drug: Iloperidone']}], 'interventions': [{'name': 'Iloperidone', 'type': 'DRUG', 'armGroupLabels': ['Iloperidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}